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FDA检验方法验证指南中英文

美国FDA分析方法验证指南中英文对照Guide to the U.S. FDA method validation Chinese and English目录ContentsI. INTRODUCTION (3)II. BACKGROUND (4)III. TYPES OF ANALYTICAL PROCEDURES (6)IV. REFERENCE STANDARDS (7)V. METHODS VALIDATION FOR INDs (10)VI. CONTENT AND FORMAT OF ANALYTICAL PROCEDURES FOR NDAs, 230ANDAs, BLAs, AND PLAs (11)VII. METHODS VALIDATION FOR NDAs, ANDAs, BLAs, AND PLAs (15)VIII. STATISTICAL ANALYSIS (23)IX. REVALIDATION (24)X. METHODS VALIDATION PACKAGE: CONTENTS AND PROCESSING (25)XI. METHODOLOGY (30)ATTACHMENT ANDA, ANDA, BLA, AND PLA SUBMISSION CONTENTS (40)ATTACHMENT BMETHODS VALIDATION PROBLEMS AND DELAY (41)GLOSSARY (42)美国FDA分析方法验证指南中英文对照I. INTRODUCTIONThis guidance provides recommendations to applicants on submittinganalytical procedures, validation data, and samples to support thedocumentation of the identity, strength, quality, purity, and potencyof drug substances and drug products.1. 绪论本指南旨在为申请者提供建议，以帮助其提交分析方法，方法验证资料和样品用于支持原料药和制剂的认定，剂量，质量，纯度和效力方面的文件。

外贸函电常用缩略语概要

A =first quality,first grade,first classA.A.R =agia nst all risksABV =aboveABT =aboutA/C,AC=accou ntACCES =accessory,accessoriesACDG =accordi ngACDGL Y=accordi nglyACEPT,ACPT=acceptACEPTD,ACPTD=acceptedACPTBL=acceptableACPTC =accepta neeACK =ack no wledge,ack no wledged,ack no wledgeme ntACOMN,ACCOMDN=accommodatio nAD =advertiseme ntADDL,ADDNL=additio nalADDN =additi onADDS,ADS=addressADJ =adjust(me ntADV =advice,adviseAFRN =afternoonAGCY =age ncyAGN =agai nAGNT =age ntAGNST,AGST=agai nstAGR =agreeAGRD =agreedAGRMT =agreeme ntAIR =airmailAIRD =airmailedAIRG =airmaili ngAIRML =airmailAIRFRT=airfreightALRDY =alreadyAM =AmericaAMAP =as many( much as possible AMDT =ame ndme ntAMDD =ame ndedAMND =ame ndAMNDMT=ame ndme nt AMNT,AMT=amou ntANS =an swerA/O =acco unt ofA/OR =an d/orAPPLCTN=applicati on APPROX,APPR=approximate(ly APV =approveAPVD =approvedARFRT =airfreightA.R. =all risksARNGMTS=arra ngeme nts APR =AprilARR,ARV=arriveART =articleARVD =arrivedARVL =arrivalA/S =at sight,after sightASA =as soon asASAP =as soo n as possible ASRTMT,ASTMT=assortme nt(for textiles BIZ ASST =assista ntASSTANCE=assista neeASSTD =assorted(for textiles BIZATCH =attach(ed(me ntATN,A TTN=atte ntionAUG =AugustAUTH =authorizeA VBL,A VLBL=availableA VTG =averageA.W.B, AWB=air way billAWTG =awaiti ngAM,A/M=above men tio neda.k.a.=also known asa.s.o.=a nd so onB =beBG =bagBAL,BALCE =bala neeB/B =bed and breakfast(for hotel BIZ BCOS,BCOZ =becauseB/D =ba nk draftBEF,BFR =beforeBGN =beginBIBI =byebyeBIZ =bus in essBK =ba nk,bookBKFST =breakfast(for hotel bus in essBKBLE,BKBL =bookableBKG =book ingB/L =Bill of Ladi ngBLCH =bleachBLDG =buildi ngBLNDD =ble nded(for textile BIZBP =British PharmacopoeiaBR =Britai nBRS =brassBSNS =busi nessBSR =basic service rate(for ocea n tran sportati on BIZ BTM =bottomBTN =buttonBTWN =betwee nBUS =bus in essBXS =boxesBYR =buyerCA =Ca nadaCAAC =Civil Aviatio n Adimi nistratio n of Chi na CAD =Ca nadia n dollar,Cash aga inst Docume nts CALIF =CaliforniaCAND =Ca nadia n dollarCAPT =capta inCAT =catalogueCBL =cableCCIB =Chi na Commodity In spect ion BureauCERT =certificateCFM =confirmCFMD =con firmedCFMG =con firmi ngCFMN,CFMTN =co nfirmationCFS =container feight stati onCFT(CBFT =cubic feetCHNG =cha ngeCHNGD =cha ngedCHQ =chequeCHRGS =chargesC」.C.,CIC =Chi na In sura nee ClauseCK =checkCLR =colorCLRWY =colourway(for textiles BIZCLSD =closedCMOS =compleme ntary metal-oxide semic on ductor C/N =credit note CNCL =ca ncelCMT =cutti ng,maki ng(ma nu facturi ng and trimmi ng CNCLN =ca ncellati on CNT,CANT =can t,ca nnotCNTR =cou nterC/O =in care of=certificate of orig inC/OFR =cou nter offerCOL =collationCOL-CARD =colour card(for textiles BIZCLOWAY =colorwayCOMM =commissio nCOMP =completeCONC =con cerni ngCOND,CONDI =con diti on CONSGNT,CONSGT=co nsig nment CONSR =con sumerCONT =con ti nueCONT,CONTR =co ntractCONTD =continuedCONTR,CTNR,CNTR=c on tai ner COOP =co-operati onCORP =cooperati onCORR,CRT =correctCOSCO =Chi na Ocean Shippi ng Co. C/P =Charter partyCR,CRED =creditCRT(S =crate,cratesC/S =case,casesC/SMPL =cou nter sampleCST(S =chest(sCSTMR =customerCTF =correct ion to followCTLG =catalogueCTN(S =carto n(sCU,CUB =cubicCUTG =cutt ingCVC =cheif value cott on(for garme nts BIZCWT =hu ndred weightCY =container yardCY/CY =container yard to container yardDALPO =do all possibleDBL =doubleDBLB =double(roomwith bathDBT =debitD/C =docume ntary credit(for banking BIZ DCRE =decrease DD,DTD =datedD/D =dema nd draftDEC =DecemberDELY =delivery DEPT =departme nt DESTN =desti nati on DFRN =differe nt,differe nee DIFF =differe neeDIR =director DIRTLY =directly DIS,DISC =discou nt DISAPV =disapprove (al DISHD =dish on ored DISRGD =disregardDIV =divide nd DLRS,DLS =dollarsDLVR =deliverDLVD =deliveredDLVRY =deliveryDL Y =delyD/N =debit noteDO =dittoDOC =docume ntsDOZ =doze nDPT =departureDR =debit,debitorDRG,DRWG=draw ingDS =daysD/S =days sight=days after sightDSGN =desig nDT =dateDTL =detail(sDUP,DUPLCT=duplicateDWN =dow nD. W.T.,DWT=deadweight ton(sDZ =dozenE/D=expire dateEDF=estimated date of flightE. E.C=Europea n Econo mic Community EEE,ERR=error EELCE=L/CEL,E/L=export lice neeEMGNCY=emerge ncyENC,ENCL=e nclosureENQURY ,ENQRY=e nquiryE.&O .E=errors and omissi ons excepted ERL Y=early EQL=equalEQUI=equivale ntESTABG=establishi ngETA=estimated time of arrivalETD=estimated time of departureEXAM=exami neEXCH,EXCHG=excha ngeEXPLN=explai nEXP=export,expireEXT=exte nd,exte nsionFACTRY=factoryFAQ=fair average qualityFA V=favourFA VRBL=favourableF/B=full board(for hotel BIZFCL=full container loadFDA=Food and Drug Adimi nistratio n( U.S.A. F/E/C=foreig n excha nge certificate f.i.=for in sta nee, free inFIG(S=figure(sFIO,F.I.O.=free in,out and stowedF. I.O.S.T=free in,out,stowed and trimmed FLT=flightFLW=followFLWG ,FOLG=followi ngFEB=FebruaryFLWS=followsFM=fromFNL=fi nalF.O.=free outFOA=FOB airportFOC=free of chargeFOR=free on railFOT=free on truckFPA=free of particular averageF.R.E.C=Fire Risk Extension Clause FRI=Friday FRT=freightFRZ=froze nFWD,FORWD=forwardFYI=for your in formatio nFYG=for your guida neeFYR=for your refere neeG/A=ge neral averageGAL,GALL=gallo nGBP=Great Brita in Pou ndGD=goodGEN=ge neralGF=gold francGLD=goldGM(S=gram(sGMQ=Good Mercha ntable Quality GMT=Gree nwich Mea n Time GNRL=ge neralG .O.H=garme nts on hangGOVT=governme ntGR=grai n,gram(meG .R.T.=gross registered tonn ageGR WT=gross,weightGSP=Ge neralized System of Prefere nces GT=gross tonGV=giveGUAR,GURANTE=guara nteeG/W=gross weightH/B=half board(for hotel BIZHGT=heightHK=HongKongHKD=HongKong dollarHk(S=ha nd(s(for textile BIZH.O=head officeHOLDY=holidayHR=here,hourHP=high pressure,horsepower HRWITH=herewithHV=haveHVB=have bee n,has bee n,had bee nHVY=heavyHWEVR,HWVR=howeverIAW= in accorda nee withI.C.C.=i nstitute cargo clauses, Intern atio nal Chamber of Commerce ICW=in conn ecti on withIFMN=i nfomatio nIL.,I/L=import licenceIMM,IMMED=immediate(lyIMMD,IMMET=immediateIMMDL Y ,IMDTL Y=immediatelyIMP=importIMPRV=improveIMPS=impossibleIMPT=importa ntIMPVD=improvedIN=i nchINCD,INCLDD=i ncludedINCDG=i ncludi ngINCL,INCLD=i ncludeINCL=i nclusiveINCR,INCRE=i ncrease INCRCT,INCOR=i ncorrect INDIV=i ndividualINF,INFM=i nformINFMD=i nformedINFMG=i nformi ngINFMTN,INFN,IFMN=i nformation INFO=i nfomatio nINP=if n ot possibleINQ=in quireINQRY=i nquiryINS=in sura neeINST=i nstallme ntINSTRCTN,INSTN=i nstruct ionINSUR=i nsura neeINTL=i nternatio nalINTRST(D=i nterest(edINTST=i nterestINV ,IVO=i nvoiceINVEST,INVSGT=i nvestigateINVSGN=i nvestigatio nl/O=in stead ofI.O.P=irrespective of perce ntageIOT=i n order toIOU=I owe youIRRESP=irrespectiveIRREV ,IRVCBL=irrevocableISO=International Standards OrganizationIVO=i n view ofJAL=Japa n Air LinesJAN=Ja nuaryJAP=JapanJCQD=jacquard(for textiles BIZ JKT=jacketJUL=JulyJUN=Ju neKANS=Ka nsasKC(S=kilocycle(sKG(S=kilogram(sKL=kiloliterKM=kilometerKP=keepKV=kilovoltKW=kilowattKWH=kilowatt-hourKY=Ke ntuckyL=letter,large,sterli ngLAB,Lab=laboratoryLB(S=pou nd(sLCD=liquid-crystal diodeLCL=less tha n cartload lot,less tha n container load LDN=L ondon LDT=light displaceme ntLED=light emitt ing diodeLET=letterL/G=letter of guara nteeLIT=litreLMT=local mea n timeLNTH=le ngthLST=local sta ndard timeLT,L/T=lo ng tonLTE=lateLTR,LTTR=letterLVE=leaveM=meter,mediumMANUF=ma nufactureMAR=MarchMAX=maximumMDL=modelMDLN=model No.MEAS,MEASMT=measureme ntMEMO=memora ndumM/F=male/femail(for ani mal by products BIZ MFD=ma nu factured MFG=ma nu facturi ngMFR=ma nu facturerMGR=ma nagerMIN=mi nimumMISG=missi ngMKR=makerMKT,MRKT=marketMNTIME=mea ntimeMON=Mo ndayMRNG=morni ng,good morningMSG=messageMSTK=mistakeM/T,MT=metric tonMRT(S=meter(sMUSTB=must beM/V,m.v.=motor vesselN=a ndN/A=non accepta neeNAR=now arrivi ngNV,N.B. nota ben e( note wellNEC,NEGTN=negotiationNEGO=negotiateNIL=no ti ngNITE=n ightNLT=not later tha nNNNN=e nd of massage sig nalNO,NBR,NR=nu mberNOV=NovemberN.R.T.=net registered tonn ageNTD=notedNU=newN/W,NTWT,NWT=net weight NXT=nextNY=New YorkNZ=New Zeala ndO/A =on or aboutO/B =on boardOBLD=obligedOBS =observeOBT =obta inOC =our cableOC5 =our cable dated 5thOCC =occupiedO.C.P,OCP=overla nd com mon poi nt OCT =OctoberODR =orderOFC =officeOFCL=officialOFF =officeOFA,OFR(S=offer(sOK =all right or agreedOL =our letterOPEC=Orga nizatio n of the Petroleum =Export ing coun triesOPN =ope nOPND=ope nedOPNG=ope ningOPT =optionORD =ordi naryORIG,ORGNL=origi nal OT =our telex,our telegram OTLX=our telexOTHWS=otherwise OURSLVS=ourselvesOZ =ounceOZWS=otherwisePA =Pe nn sylva nia PACKG=pack ing PAMP,PAM=pamphlet PAT =pate ntPATTN=patter n PAYMT,PAYT=payme nt PCE,PC=piecePCT =perce ntPCTG=perce ntagePENN=Pe nn sylva niaPHLN=Philippi nePIA =Pakista n Air LinesP/INV=proforma inv oiceP」.C.C.=The Peoples In sura nee Co. of Chi na PKG =pack in g,package PKTS=packetsPLS,PL=pleasePLT(S=plate(sPOL Y=polyesterPOSN=positi onPOSS,POSSBL=possiblePRC =pricePREV=previousPROB=probablePROBM=problemPROD=produti onPROX=proximoPRVS=previousPRVT=privateP.S.T.,PST=Pacific Sta ndard Time(U.S.A. PUR =purchase PURCHS=purchasePURP=purposePVC=polyvi nyl chloridePYMT=payme ntQLTY =qualityQNTY =qua ntityQOT =quoteQSTN =questionQTN,QUTN=quotatio nQUOT,QUOTN=quotatio nR =areRCPT =receiptRCV =receiveRCVD =receivedRCVG ,RECVG=receivi ngRD =read,roadRE =referri ngRECD,RECVD=receivedREF =refere neeREFCON=refrigerated container REG =registerREFD registeredREGDG=regardi ngREGL =regularREIMB=reimburseme nt RELTNS=relatio ns RESPCTVL Y=respectively REQ,REQST=request REQMNT=requireme ntREQR =requireREQRMT=requireme ntREP =represe ntativeREPT =reportRESN =reservati onRESP =respectiveRESV =reserveREV =revisedRGDS =regards,best regardsRMKS =remarksRND =rou ndR/O =room only (without breakfast(for hotel bus in ess ROC =refer to our cable ROC8/2=refer to our cable dated Feb.8ROL =refer to our letterRO/RO=roll o n/roll offR/O/T=roll on tube(for textiles bus in essROT =refer to our telegram(telexROTLX=refer to our telexRPT =repeat,reportRPTN =repetiti onRPY =replyRQST =requestREPON=respo nsible(bilityR.S.V .P.=please reply(rep on dez sil vous plaitRTRN =returnRYC =refer to your cableRYL =refer to your letterRYT =refer to your telexRYTLX=refer to your telex of August 24RYTLX24/8=refer to your telex of August 24S =smallSA =saySAT =SaturdayS.A.T.=sea-air-truckSBJ =subjectSCHDL=scheduleSCIB=Sha nghai Commodity In spect ion Bureau S/D =shipme nt date SDR(S=special draw ing right(sSDG =se ndingSDY =Syd neySEC =sect ionSERV=serviceShai=Sha nghaiSHIPD=shippedSHIPT=shipme ntSHP =shipSHPG=shipp ingSHPMT,SHIPMT=shipme ntSHPT=shipme ntSHUD=shouldSHUDB=should beSITN=situationSLR =silverSLV =sleeve(sS/MARKS=shipp ing marksSMPL=sampleSNGB=si ngle(roomwith bath(for hotel bus in ess SNGL=s in gle,si ngle room(for hotel bus in ess SNGS=si ngle room with showerSPCL=specialSPEC(S=specificatio n(sSPORE Spore=Si ngaporeSQYD=square yardS.R .C.C.=Strikes,Riots and Civil Commotio ns SRY =sorryS.S.,S/S=steamshipSTD =sta ndardSTG =sterli ngSTL =stillSTN =stationSTP =stopSUB,SUBJ=subjectSUGG,SUGST=suggestSUPL=suppleme ntSUPL Y=supplySURV=surveySVP =please(sil vous plait SWG =Sta ndard Wire Gauge SWH =Swatch(for garme nts BIZ SZ =size。

ICH领域专业术语-欧盟GMP附录术语-FDA有关术语[1]

ICH领域专业术语-欧盟GMP附录术语-FDA有关术语[1]ICH领域专业术语表（质量、安全性）序号英文中文1 absorption 吸收2 acceptable daily intake 可接受的日摄入量3 accelerated test 加速试验4 acceptance criteia 认可标准5 accuracy 准确性6 accelerated/stress stability studies 加速/强力破坏稳定性研究7 action limits 内控限值8 active ingredient 活性组分9 active metabolite 活性代谢产物10 additional test 附加实验11 additions 添加剂12 adduct 加合物13 adequate exposure 充分暴露14 adjuvant 佐剂15 administration period 给药期16 adventitious agents 外源性因子17 adventitious contaminants 外来污染物18 adventitious viruses 外源病毒19 adverse reaction 不良反应20 aerobic microorganisms 需氧微生物21 affinity 亲和力22 affinity chromatography 亲和层析23 affinity column 亲和柱24 agar and broth 琼脂和肉汤25 aggregation 聚集26 altered growth 生长改变27 ambient condition 自然条件28 amino acid sequence 氨基酸顺序29 amino acids 氨基酸30 amino sugars 氨基糖31 analytical method 分析方法32 antibiotics 抗生素33 antibody 抗体34 antibody production tests 抗体产生试验35 antigenic specificity 抗原特异性36 applicant 申报者37 art and ethical standards 技术和伦理标准38 assessment of genotoxicity 遗传毒性评价39 attainment of full sexual function 达到性成熟40 avidity 亲和性41 background 背景42 bacteria 细菌43 base pairs 碱基对44 base set of strains 基本菌株45 base substitution 碱基置换46 batches 批次47 batch-to-batch 逐批48 between-assay variation 试验间变异49 bioburden 生长量/生物负荷50 biochemical methods 生化方法51 biological products 生物制品52 biological relevance 生物学意义53 bioreactor 生物反应器54 birth 出生55 blood plasma factors 血浆因子56 body burden 机体负担57 body fluids 体液58 by-products 副产物59 C(time)一定剂量、某一时间的浓度60 calibrate 标化61 capillary electrophoresis 毛细管电泳62 carbohydrate 碳水化合物63 carboxy-terminal amino acids 羧基端氨基酸64 carcinogen 致癌物质65 carcinogenesis 致癌性66 carcinogenic hazard 致癌性危害67 carrier 载体/担体68 case-by-case 个例69 catalysts 催化剂70 cell bank 细胞库71 cell bank system 细胞库系统72 cell cultures 细胞培养物73 cell cultures 细胞培养74 cell expansion 细胞扩增75 cell fusion 细胞融合76 cell line 细胞系77 cell lines 细胞系78 cell metabolites 细胞代谢物79 cell pooling 细胞混合80 cell proliferation 细胞增植81 cell replication system 细胞复制系统82 cell substrates 细胞基质83 cell suspension 细胞悬液84 cell viability 细胞活力85 central nervous systems 中枢神经系统86 charcoal 活性炭87 charge 电荷88 chromatograms 色谱图89 chromatographic behavior 色谱行为90 chromatographic procedures 色谱方法91 chromatography columns 色谱分离柱92 colony sizing 集落大小93 confidence interval 置信区间94 confidence limits 可信限95 consistency 一致性96 container 容器97 container/closure 容器/闭塞物98 container/closure integrity testing 容器/密封完整性试验99 contaminants 污染物100 content uniformity 含量均匀度101 continuous treatment 连续接触102 control methodology 控制方法学103 controlled released product 控释制剂104 conventional live virus vaccines 传统的活病毒疫苗105 conventional vaccines 传统疫苗106 correction factor 校正因子107 correlation coefficient 相关系数108 cross-contamination 交叉污染109 cross-linking agent 交联剂110 cross-reactivity 交叉反应111 cryopreservation 冷冻保存112 cryoprotectants 防冻剂113 crystals 晶体114 culture components 培养基成分115 culture condiction 培养条件116 culture media/medium 培养基117 decision flow chart/tree 判断图118 Degradation 降解产物119 degradation 降解120 degradation pathway 降解途径121 degree of scatter 离散程度122 delay of parturition 分娩延迟123 descriptive statistics 描述性统计124 detection limit 检测限度125 dissolution testing 溶出试验126 dissolution time 溶出时间127 distribution 分布128 dosage form 剂型129 dose dependence 剂量依赖关系130 dose level 剂量水平131 dose -limiting toxicity 剂量限制性毒性132 dose-ranging studies 剂量范围研究133 dose-related 剂量相关134 dosing route 给药途径135 downstream purification 下游纯化136 drug product 制剂137 drug product components 制剂组方138 drug substances 原料药139 duration 周期140 endotoxins 内毒素141 end-point 终点142 end-product sterility testing 最终产品的无菌试验143 enhancers 增强子144 enzyme 酶145 evaluation of test result 试验结果评价146 ex vivo 体外147 excipient 赋形剂148 expiration date/dating 失效日期149 exposure assessment 接触剂量评价150 exposure level 暴露程度151 exposure period 接触期152 expression system 表达系统153 expression vector 表达载体154 extended-release 延时释放155 extent of the virus test 病毒测试的程度156 false negative result 假阴性结果157 false positive result 假阳性结果158 fecundity 多产159 feed-back 反馈160 fermentation 发酵161 fermentation products 发酵产品162 fill volume 装量163 filter aids 过滤介质164 final manufacturing 最终生产165 finished product 成品166 first pass testing 一期试验167 forced degradation testing 强制降解试验168 formal labeling 正式标签169 formal stability studies 正式的稳定性研究170 formulation 处方/配方171 formulation 制剂172 freeze-dried product 冻干产品173 fresh dissection technique 新鲜切片技术174 friability 脆碎度175 functional deficits 功能性指标176 functional test 功能试验177 growth factors 生长因子178 growth hormones 生长激素179 half-life 半衰期180 hardness 硬度181 heavy metals 重金属182 herbal products 草药183 host cell 宿主细胞184 host cell banks 宿主细胞库185 host cell DNA 宿主细胞DNA186 host cell proteins 宿主细胞蛋白质187 humidity 湿度188 humidity-protecting containers 防湿容器189 immediate container/closure 直接接触的容器/密闭物190 immediate pack 内包装191 immediate release 立即释放192 immortalization 激活193 in vitro 体外194 in vitro and in vivo inoculation tests 体内和体外接种试验195 in vitro assay 体外检测196 in vitro cell age 体外细胞传代期197 in vitro lifespan 体外生命周期198 in vitro test 体外试验199 in vitro tests 体外试验200 in vitro/in vivo correlation 体内体外相关性201 in vivo 体内202 in vivo assays 体内检测203 in vivo test 体内试验204 inactivated vaccine 灭活疫苗205 independent test 独立试验206 indicator cell 指示细胞207 indicator organisms 指示菌208 influenza virus 流感病毒209 inhalation 吸入210 inhalation dosage forms 吸入剂型211 in-house 内部的212 in-house criterea 内控标准213 initial filing 原始文件214 initial submission 最初申报215 initial text 最初文本216 inoculation 接种217 inorganic impurities 无机杂质218 inorganic mineral 无机矿物质219 inorganic salts 无机盐220 in-process acceptance criteia 生产过程认可标准221 in-process controls 生产过程中控制222 in-process testing 生产过程中检测223 intended effect 预期效果224 intended storage period 预期的贮藏期225 intentional degradation 人为降解226 interactions 相互作用227 intermediate 中间体228 intermediates 半成品229 internal control 内对照230 international reference standards 国际参比标准品231 ion-exchange 离子交换232 ionic content 离子含量233 isoelectric focusing/isoelectrofocusing 等电聚焦234 Jp/Ph.Eur./Usp. 日本药局方/欧洲药典/美国药典235 Level of safety 安全水平236 Libido 性欲237 Life threatering 危及生命238 ligand 配位体/配体239 light 光照240 light resistant packaging 避光包装241 limit of acceptance 可接受的限度242 limit test 限度试验243 limulus amoebocyte lysate 鲎试剂244 linear relation ship 线性关系245 linearity 线性246 liquid nitrogen 液氮247 liquid oral dosage forms 液体口服制剂248 long term test 长期试验249 Long-term carcinogenicity study 长期致癌性试验250 long-time and accelerated stability 长期和加速稳定性试验251 Loss of the tk gene tk 基因丢失252 losses of activity 活性丧失253 lot release 批签发254 low molecular weight subsances 低分子量物质255 lower-observed effect level (LOEL) 能观察到反应的最低量256 manufacturing scale 生产规模257 marieting pack 上市包装258 marker chromosome 标志染色体259 Marketing approval 上市许可260 mass 重量261 mass balance 质量平衡262 mass spectrometry 质谱263 master cell bank (MCB) 主细胞库264 matrixing 每日最大剂量265 Metabolism 代谢266 microbial expression system 微生物表达系统267 microbial limits 微生物限度268 microbial metabolites 微生物代谢物269 microbiological testing 微生物学试验270 Micronucleus 微核271 minimum of pilot plant 试产规模272 moisture level 水分273 primary structure 一级结构274 primer 引物275 probability 概率276 process controls 工艺控制277 process optimisation 工艺优化278 process parameters 工艺参数279 process validation 工艺确证280 process-related impurities 工艺相关杂质281 Pro-drug 前体药物282 product-related imputies 产品相关杂质283 promoters 启动子284 proposed commercial process 模拟上市285 protected samples 避光样品286 proteins 蛋白质287 proteolysis 蛋白水解288 protocol 方案289 purification 纯化290 purified antigens 纯化抗原291 purity 纯度292 purity test 纯度试验293 pyrogens 热原294 qualification 界定295 qualified 合格的296 quality standards 质量标准297 quantitation limit 定量限度298 quantitative characteristics 定量参数299 quantitative detection 定量检测300 quantitative method 定量方法301 quantitative test 定量试验302 quantitative virus assays 病毒定量分析303 quantity 含量304 reagent 试剂、反应物305 real condition 真实条件306 real time 真实时间307 receptor 受体308 reference standard 参比标准品309 regimen 方案310 registration application 注册申请311 regression analysis 回归分析312 related substances 有关物质313 release limit 出厂限度314 Relevant animal species 相关动物种属315 Relevant dose 相关剂量316 Relevant factor 相关因素317 repeatability 重复性318 reproducibility 重现性319 residual lolvents content 溶剂残留量320 residual solvents 残留溶剂321 retention time 保留时间322 retest date 再试验日期323 Reversibility 可恢复性（可逆性）324 revived cells 复苏的细胞325 Risk assessment 危险度评价326 Route of administration 给药途径327 Routine testing 常规试验328 Safegards 安全监测329 Safety margin 安全范围330 Safety pharmacology 安全药理学331 sampling 采样332 Sampling time 采样时间333 scale-up 放大334 scaling down 缩小规模335 scope 范围336 scrapie 瘙痒病337 screening tests 筛选试验338 SDS-PAGE/SDS-polyacrylamide gelelectrophoresis十二烷基磺酸钠-聚丙烯酰胺凝胶电泳339 sealed ampoules 密封安瓿340 secondary structure 二级结构341 Secondary testing 二期试验342 self-replicating agents 自我复制因子343 semi-synthetic products 半成品产品344 Sensitive periods 敏感期345 sensitivity 灵敏度346 serum 血清347 shelf life 货架寿命348 shipmjent 运输349 Short term toxicity 短期毒性350 Short treatment 短期处理351 Single dose(acute)toxicity 单剂量（急性）毒性352 single-dose and multipledose packages 单剂量和多剂量包装353 Site-specific targeted delivery 定位靶向释放354 Small colony 小集落355 solid oral doseage 固体口服制剂356 solvent 溶剂357 Solvent control 溶剂对照358 Somatic cell 体细胞359 specification 规范360 specification limit 规范限度361 specification-check 质控规范362 specification-release 出厂规范363 stability data 稳定性资料364 stability evaluation 稳定性评价365 stability protocol 稳定性方案366 stability study duration 稳定性试验期限367 stability testing 稳定性试验368 standard deviation 标准差369 Standard procedure 标准规程370 Standard protocol 标准试验方案371 starting materials 起始物372 statement/labelling 说明/标签373 statistical analysis 统计学分析374 Statistical evaluation 统计学评价375 Step-by-step 逐步376 sterility 无菌377 storage condition 放置条件378 stress condition 强力破坏试验条件379 stress testing 强力破坏试验380 strorage conditions 贮存条件381 Structural changes 结构改变382 Suspension 悬浮物383 suspensions 混悬剂384 synthesis 合成385 synthetic peptides 合成肽386 Target cell 靶细胞387 Target histidine genes 组氨酸目的基因388 target molecule 靶分子389 Target organs 靶器官390 Target tissue 靶组织391 temperature changes 温度变化392 teriary structure 三级结构393 terminology 术语394 Test approach 试验方法395 Test battery approach 试验组合方法396 Test compound 受试物397 test criteria 试验标准398 test intervals 试验间隔399 Test model 试验模型400 test parameters 试验参数401 Test strategy 试验策略402 Test systems 试验系统403 Tester strain 试验菌株404 testing frequency 试验次数405 Therapeutic 治疗406 Therapeutic confirmatory 疗效确定407 Therapeutic exploratory 疗效探索408 Therapeutic indication 治疗适应证409 threshold limits 阈值410 Time course 时程411 Timing conventions 分段计时方法412 titration 滴定法413 tolerable daily intake 可耐受的日摄入量414 Top concentration 最高浓度415 Topical 局部的416 transcription 转录417 transdermal systems 透皮吸收系统418 transfection 转染419 transformation 转化420 Translocation 移位421 Tumor response 肿瘤反应422 tumorigenicity 致瘤性423 uniformity of content 含量均匀度424 universal tests/criteria 常规试验/标准425 UV/visible wavelength 紫外/可见光波长426 vaccines 疫苗427 validation 论证428 variants 变异体429 vector 载体430 visual appearance 外观431 visual evaluation 直观评价432 vitamins 维生素433 western blot 免疫印迹434 Whole blood 全血435 working cell bank 工作细胞库436 yeast 酵母437 y-intercept y轴上的截距FDA有关术语FDA（food and drug administration) （美国）食品药品管理局IND（investigational new drug）临床研究申请NDA（new drug application）新药申请ANDA（abbreviated new drug application 新药简化申请EP （export application）出口药申请Treatment ind 研究中的新药用于治疗Abbreviated（new）drug 药物简化申请DMF（drug master file 药物主控文件holder dmf持有者CFR（code of federal regulation）（美国）联邦法规panel 专家小组batch production 批量生产；分批生产batch production records 批生产记录post-or pre- market surveillance 销售前或销售后监督informed consent 知情同意prescription drug 处方药OTC drug（over—the—counter drug）非处方药US．public health service 美国卫生福利部NIH（national institute of health）（美国）全国卫生研究所clinical trial 临床试验animal trial 动物试验accelerated approval 加速批准standard drug 标准药物investigator 研究人员；调研人员preparing and submitting 起草和申报submission 申报；递交benifit（s）受益risk（s）受害，风险drug product 药物产品drug substance 原料药established name 确定的名称generic name 非专利名称proprietary name 专有名称INN（international nonproprietary name）国际非专有名称，通用名narrative summary 记叙体概要adverse effect 副作用adverse reaction 不良反应protocol 方案archival copy 存档用副本review copy 审查用副本official compendium 法定药典（主要指USP\NF）USP（the united states pharmacopeia）美国药典（现已和nf 合并一起出版）NF（national formulary) （美国）国家药品集official＝pharmacopeial= compendial 药典的；法定的；官方的agency 审理部门（指FDA）sponsor 主办者（指负责并着手临床研究者）identity 真伪；鉴别；特性strength 规格；规格含量labeled amount 标示量regulatory specification 质量管理规格标准（nda提供）regulatory methodology 质量管理方法regulatory methods validation 管理用分析方法的验证dietary supplement 食用补充品欧盟GMP附录术语Air-lock 气锁Batch (or lot) 批Batch number (or lot number) 批号 Biogenerator 生物反应器Biological agents 生物载体Bulk product 待包装产品 Calibration 校准Cell bank 细胞库Cell culture 细胞培养物 Clean area 洁净区Clean/contained area 洁净/隔离区域 Containment 隔离Contained area 隔离区域Controlled area 控制区/受控区域Computerized system 计算机化的系统Cross contamination 交叉污染Crude plant (Vegetable drug) 天然植物 Cryogenic vessel 低温容器 Cylinder 气体钢瓶Exotic organism 外来生物体 Finished product 成品Herbal medicinal product 草本药物产品 Infected 感染In-process control 中间控制Intermediate product 中间产品Liquefiable gases 液化的气体Manifold 多支管灌装头Manufacturer 制造企业 Medicinal plant 药用植物 Packaging 包装Packaging material 包装材料Procedures 规程Production 生产Qualification 确认Quality control 质量控制Quarantine 待检Radiopharmaceutical 放射性药品 Reconciliation 数额平衡 Record 记录Recovery 回收 Reprocessing 返工处理 Return 退货/退回Seed lot 种子批Specification 质量标准/规格Starting material 起始物料Sterility 无菌System 系统 Validation 验证。

药品注册英文

欢迎阅读Glossary （术语）：RegulatoryAffairs （RA ）：药政事务drugauthority ：药政当局investigationandresearchbeforeprojectapproval ：立项前的调研MarketAuthorization （MA ）：上市许可lifecycle genericdrug ：仿制药CenterforDrugEvaluation （CDE ）：SFDA 下属的药品审评中心QualitybyDesign （QbD ）：质量源于设计CMCPilotProgram ：FDA 在业内开展的关于QbD 的试点研究earlylaunch ：早日上市designspace：设计空间BusinessDevelopment（BD）：业务发展部门ImportedDrugLicense（IDL）：进口药品注册证ManufacturingLicense（ML）：生产许可证ClinicalTrialPermission（CTP）：临床试验批件marketshare：市场占有率salesvolume：销量investigatorbrochure（IB）：研究者手册protocol：临床试验方案priority：优先度packageinsert（PI）：说明书labeling：包装标签PatientInformationLeaflet（PIL）：患者使用的说明书SummaryofProductCharacteristics（SmPC，SPC）：产品特性摘要foil：铝箔carton：装药品的小盒Medical（ClinicalCommercial：商业部门newchemicalentity（NCE）：新化学实体keyopinionleader（KOL）：关键意见领袖off-labeluse：标签外使用patientpool：患者库deadline：最后期限globaltrial：全球性的临床试验，即国际多中心临床试验regionaltrial：区域性的临床试验TPD加拿大卫生部治疗产品局adversedrugreaction,ADR药物不良反应pharmacokinetics(PK)药物代谢动力学。

FDA 行业指南中英对照待完成

Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS目录I. INTRODUCTION介绍II. BACKGROUND 背景A. Definitions 定义B. CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和USP对容器和密封的要求C. Additional Considerations 其他需要考虑的事项III. QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS包装组件的合格要求以及质量控制A. Introduction 介绍B. General Considerations 通常要求C. Information That Should Be Submitted in Support of an Original Application for AnyDrug Product 为支持任何药品的原始申请所必须提供的信息D. Inhalation Drug Products 吸入性药品E. Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药F. Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体口服和外用药品和外用给药系统G. Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末H. Other Dosage Forms 其他剂型IV. POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更V. TYPE III DRUG MASTER FILES 药品主文件第III类A. General Comments 总体评述B. Information in a Type III DMF 第III类DMF中包括的信息VI. BULK CONTAINERS 大包装容器A. Containers for Bulk Drug Substances 用于原料药的容器B. Containers for Bulk Drug Products 用于散装药品的容器ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件CEXTRACTION STUDIES “提取性”研究ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls DocumentationI．INTRODUCTION介绍This document is intended to provide guidance on general principles2 for submitting information on packaging materials used for human drugs and biologics.3 This guidance supersedes theFDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics ,issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs.4 This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture. 本文件目的是为递交人用药品和生物制品的包装信息提供总体原则指南。

【医疗药品管理】美国FDA原料药生产质量管理规范(中英文)

DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OFRAW MATERIALS BY FDA美国FDA原料药生产质量管理规范（中英文）Table of Contents 目录1. INTRODUCTION 简介1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 范围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 内部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

美国FDA食品生产企业GMP法规

美国FDA食品生产企业GMP法规A 总则§110.3定义联邦食品、药物及化妆品法（以下简称该法案）第210节中术语的定义和解释适用于本法规的同类术语，下列定义亦同样适用：（a）酸性食品或酸化食品（Acid foods or acidified foods）：平衡pH值等于或低于4.6的食品。

（b）适当的（Adequate）为完成良好公共卫生规范的预定目标所需要的要求。

（c）面糊（Batter）：一种半流体物质，通常包含面粉和其它成分。

可在其中浸蘸食品的主要成分，或用它涂在外表，或直接用它制成焙烤食品。

（d）烫漂（Blanching）：在包装前对食品（不包括树生坚果和花生）进行热处理，使天然酶部分或完全失活，并使该食品发生物理或生化的变化。

（e）关键控制点（Critical control point）：食品加工过程中的一个点，若该点控制不当，极可能造成、引发或导致危害，或导致成品污染，或导致成品分解。

（f）食品（Food）：指210法案（f）节所定义的食品，包括各种原料和配料。

（g）食品接触面（Food contact surfaces）：接触食品的那些表面以及经常在正常加工过程中会将污水滴溅在食品上或溅在接触食品的那些表面上的表面。

”食品接触面”包括用具及接触食品的设备表面。

（h）批（Lot）：在某一时间段内生产的用具体编号标记的食品。

（i）微生物（Microorganisms）：酵母菌、霉菌、细菌和病毒，并包括但不限于对公众健康产生影响的那些微生物种类。

”不良微生物（undesirable microorganisms）”包括那些对公众健康产生显著影响的微生物，会使食品分解的微生物，会使食品受到杂质污染的微生物，或使食品成为该法案所指的掺杂食品的微生物。

在某些情况下，美国FDA在这些法规中使用形容词”微生物的（microbial）”，替代包含”微生物（microorganism）”的形容词短语。

美国现行GMP规范及实施

执行规范
cGMP, GCP 和 GLP 这些规范是对药物旳开发、临床和生产旳监控和管理
FDA 药物注册
IND, NDA, ANDA, 动物 NDA FAP – 食品添加剂 510(k) – 医疗器械
要求临床试验和市场分布信息资料
提交生产、检测、仓储信息
PRODUCT REGISTRATIONS 药物注册
Products
TYPE OF PHARMACEUTICAL BUSINESS 药物类型
处方药非专利药（一般药、仿制药）生物技术药非处方药动物用药其他:诊疗用药、放射用药、维他命类、营养增补剂、医疗器械
HISTORY OF DRUG REGULATIONS 药物法规旳历史
1923年，《纯食品和药物法》第一部美国药物法规有关药物旳掺假和标签误导药物要符合USP和NF旳含量与纯度旳要求化装品和医疗器械
向申请人发出“决定函”
NDA AND ANDA
创新药一首次在美国上市旳药物，其拥有注册商名称（NDA）
仿制药（非专利药）－已获FDA同意旳新药旳仿制品，它与拥有商标注册名旳药物有相同化学名 (ANDA)
ANDA FOR GENERIC PRODUCT 仿制药（非专利药）旳ANDA
《WAXMANHATCH法》，1984年
组织与人员
质控部门人员资格人员职责顾问
cGMP SUBPART C
BUILDING AND FACILITIES 厂房、设施与设备
设计与构造特征采光
通风，空气旳过滤、加热与冷却
设计、大小和位置
构造
清洁与保养
自动、机械与电子设备
滤器
cGMP SUBPART E CONTROL OF COMPONENTS AND

美国玩具ASTM F963标准测试项目

ASTM F963标准测试项目ASTM F963标准中关于物理和机械性能的要求主要涉及到：冲击试验、跌落试验、部件移取的拉力试验、压力试验、挠曲试验等等。

2007年版本的对声响玩具测试要求作了修订，同时增加了玩具中使用磁铁的具体规定。

玩具易燃性测试程序按照16CFR 1500.44的要求，对玩具进行水平燃烧，并规定玩具起火后沿主轴线的自行燃烧速度要低于2.5 mm/s 。

ASTM F963的化学测试除了针对油墨、油漆、涂层等的8大重金属测试外，还要根据16CFR 1303的内容对总铅有要求，其限值为600ppm 。

除此之外，还涉及到填充物材料清洁度（Pennsylvania’s Regulation ）、PVC 中增塑剂DEHP 含量（ASTM D3421）等测试。

美国玩具安全测试要求具体见下表：测试类别玩具测试项目规范、标准方法物理和机械性能测试(Physical and mechanical tests) ASTM F963-03可燃性测试 (Flammability tests)ASTM F963-03 4.2US 16 CFR 1500.44 and 16 CFR 1610 化学元素迁移测试(八个元素) (Migration of elements antimony, chromium, selenium, arsenic, cadmium, mercury, barium, lead)ASTM F963-03 4.3.5涂层、油漆(总铅)(Paints and Coating materials, Total Lead)US 16 CFR 1303 玩具及儿童产品 (Toys and children’s products基本要求安全测试(如果是电动玩具)(Safety tests, if Battery or Electron operated toys)ASTM F963-03 Clauses 4.25 and8.18填充物洁净测试 (Stuffing cleanliness test) ASTM F963-03 4.3.7陶瓷和陶瓷玩具部件中的铅和镉(Ceramicware and ceramic toy components - Leachable lead and cadmium )ASTM F963-03 4.3.3.2 US FDA Compliance Policy Guide7117.06 (1995), 7117.07 (1995) 其他项目PVC 塑料中的增塑剂DEHP 含量ASTM F963-03 4.3.8ASTM D3421-75 withmodifications美國玩具標準ASTM F963-03(4.3.5) 測試項目1 法規限值溶出鉛 90 mg/kg 溶出銻 60 mg/kg 溶出砷 25 mg/kg 溶出鋇 1000 mg/kg 溶出鎘 75 mg/kg 溶出鉻 60 mg/kg 溶出汞 60 mg/kg 溶出硒 500 mg/kg 總鉛 600 mg/kg。

外贸函电常用缩写

.外贸函电常用缩略语A =first quality,first grade,first classA.A.R =agianst all risksABV =aboveABT =aboutA/C,AC=accountACCES =accessory,accessoriesACDG =accordingACDGLY=accordinglyACEPT,ACPT=acceptACEPTD,ACPTD=acceptedACPTBL=acceptableACPTC =acceptanceACK =acknowledge,acknowledged,acknowledgementACOMN,ACCOMDN=accommodationAD =advertisementADDL,ADDNL=additionalADDN =additionADDS,ADS=addressADJ =adjust〔ment〕ADV =advice,adviseAFRN =afternoonAGCY =agencyAGNT =agentAGNST,AGST=againstAGR =agreeAGRD =agreedAGRMT =agreementAIR =airmailAIRD =airmailedAIRG =airmailingAIRML =airmailAIRFRT=airfreightALRDY =alreadyAM =AmericaAMAP =as many〔much〕as possibleAMDT =amendmentAMDD =amendedAMND =amendAMNDMT=amendmentAMNT,AMT=amountANS =answerA/O =account ofA/OR =and/orAPPLCTN=applicationAPPROX,APPR=approximate〔ly〕APVD =approvedARFRT =airfreightA.R. =all risksARNGMTS=arrangementsAPR =AprilARR,ARV=arriveART =articleARVD =arrivedARVL =arrivalA/S =at sight,after sightASA =as soon asASAP =as soon as possibleASRTMT,ASTMT=assortment〔for textiles BIZ〕ASST =assistantASSTANCE=assistanceASSTD =assorted〔for textiles BIZ〕ATCH =attach〔ed〕〔ment〕ATN,ATTN=attentionAUG =AugustAUTH =authorizeAVBL,AVLBL=availableAVTG =averageA.W.B, AWB=air way billAWTG =awaitingAM,A/M=above mentioneda.k.a.=also known asa.s.o.=and so onB =beBG =bagBAL,BALCE =balanceB/B =bed and breakfast〔for hotel BIZ〕BCOS,BCOZ =becauseB/D =bank draftBEF,BFR =beforeBGN =beginBIBI =byebyeBIZ =businessBK =bank,bookBKFST =breakfast〔for hotel business〕BKBLE,BKBL =bookableBKG =bookingB/L =Bill of LadingBLCH =bleachBLDG =buildingBLNDD =blended〔for textile BIZ〕BP =British PharmacopoeiaBR =BritainBRS =brassBSNS =businessBSR =basic service rate〔for ocean transportation BIZ〕BTM =bottomBTN =buttonBTWN =betweenBUS =businessBXS =boxesBYR =buyerCA =CanadaCAAC =Civil Aviation Adiministration of ChinaCAD =Canadian dollar,Cash against DocumentsCALIF =CaliforniaCAND =Canadian dollarCAPT =captainCAT =catalogueCBL =cableCCIB =China CoMModity Inspection BureauCERT =certificateCFM =confirmCFMD =confirmedCFMG =confirmingCFMN,CFMTN =confirmationCFS =container feight stationCFT〔CBFT〕=cubic feetCHNG =changeCHNGD =changedCHQ =chequeCHRGS =chargesC.I.C.,CIC =China Insurance ClauseCK =checkCLR =colorCLRWY =colourway〔for textiles BIZ〕CLSD =closedCMOS =complementary metal-oxide semiconductorC/N =credit noteCNCL =cancelCMT =cutting,making〔manufacturing〕and trimming CNCLN =cancellationCNT,CANT =can't,cannotCNTR =counterC/O =in care of=certificate of originC/OFR =counter offerCOL =collationCOL-CARD =colour card〔for textiles BIZ〕CLOWAY =colorwayCOMM =commission. COMP =completeCONC =concerningCOND,CONDI =conditionCONSGNT,CONSGT=consignmentCONSR =consumerCONT =continueCONT,CONTR =contractCONTD =continuedCONTR,CTNR,CNTR=containerCOOP =co-operationCORP =cooperationCORR,CRT =correctCOSCO =China Ocean Shipping Co.C/P =Charter partyCR,CRED =creditCRT〔S〕=crate,cratesC/S =case,casesC/SMPL =counter sampleCST〔S〕=chest〔s〕CSTMR =customerCTF =correction to followCTLG =catalogueCTN〔S〕=carton〔s〕CU,CUB =cubic. CUTG =cuttingCVC =cheif value cotton〔for garments BIZ〕CWT =hundred weightCY =container yardCY/CY =container yard to container yard DALPO =do all possibleDBL =doubleDBLB =double〔room〕with bathDBT =debitD/C =documentary credit〔for banking BIZ〕DCRE =decreaseDD,DTD =datedD/D =demand draftDEC =DecemberDELY =deliveryDEPT =departmentDESTN =destinationDFRN =different,differenceDIFF =differenceDIR =directorDIRTLY =directlyDIS,DISC =discountDISAPV =disapprove〔al〕DISHD =dishonored.DISRGD =disregardDIV =dividendDLRS,DLS =dollarsDLVR =deliverDLVD =deliveredDLVRY =deliveryDLY =delyD/N =debit noteDO =dittoDOC =documentsDOZ =dozenDPT =departureDR =debit,debitorDRG,DRWG=drawingDS =daysD/S =days sight=days after sightDSGN =designDT =dateDTL =detail〔s〕DUP,DUPLCT=duplicateDWN =downD.W.T.,DWT=deadweight ton〔s〕DZ =dozenE/D=expire date. EDF=estimated date of flightE.E.C=European Economic CommunityEEE,ERR=errorEELCE=L/CEL,E/L=export licenceEMGNCY=emergencyENC,ENCL=enclosureENQURY,ENQRY=enquiryE.&O.E=errors and omissions exceptedERLY=earlyEQL=equalEQUI=equivalentESTABG=establishingETA=estimated time of arrivalETD=estimated time of departureEXAM=examineEXCH,EXCHG=exchangeEXPLN=explainEXP=export,expireEXT=extend,extensionFACTRY=factoryFAQ=fair average qualityFAV=favourFAVRBL=favourable. F/B=full board〔for hotel BIZ〕FCL=full container loadFDA=Food and Drug Adiministration〔U.S.A.〕F/E/C=foreign exchange certificatef.i.=for instance, free inFIG〔S〕=figure〔s〕FIO,F.I.O.=free in,out and stowedF.I.O.S.T=free in,out,stowed and trimmedFLT=flightFLW=followFLWG,FOLG=followingFEB=FebruaryFLWS=followsFM=fromFNL=finalF.O.=free outFOA=FOB airportFOC=free of chargeFOR=free on railFOT=free on truckFPA=free of particular averageF.R.E.C=Fire Risk Extension ClauseFRI=FridayFRT=freight.FRZ=frozenFWD,FORWD=forwardFYI=for your informationFYG=for your guidanceFYR=for your referenceG/A=general averageGAL,GALL=gallonGBP=Great Britain PoundGD=goodGEN=generalGF=gold francGLD=goldGM〔S〕=gram〔s〕GMQ=Good Merchantable QualityGMT=Greenwich Mean TimeGNRL=generalG.O.H=garments on hangGOVT=governmentGR=grain,gram〔me〕G.R.T.=gross registered tonnageGR WT=gross,weightGSP=Generalized System of PreferencesGT=gross tonGV=give.GUAR,GURANTE=guaranteeG/W=gross weightH/B=half board〔for hotel BIZ〕HGT=heightHK=HongKongHKD=HongKong dollarHk〔S〕=hand〔s〕〔for textile BIZ〕H.O=head officeHOLDY=holidayHR=here,hourHP=high pressure,horsepowerHRWITH=herewithHV=haveHVB=have been,has been,had beenHVY=heavyHWEVR,HWVR=howeverIAW=in accordance withI.C.C.=institute cargo clauses, International Chamber of CoMMerceICW=in connection withIFMN=infomationIL.,I/L=import licenceIMM,IMMED=immediate〔ly〕IMMD,IMMET=immediateIMMDLY,IMDTLY=immediately. IMP=importIMPRV=improveIMPS=impossibleIMPT=importantIMPVD=improvedIN=inchINCD,INCLDD=includedINCDG=includingINCL,INCLD=includeINCL=inclusiveINCR,INCRE=increaseINCRCT,INCOR=incorrectINDIV=individualINF,INFM=informINFMD=informedINFMG=informingINFMTN,INFN,IFMN=informationINFO=infomationINP=if not possibleINQ=inquireINQRY=inquiryINS=insuranceINST=installmentINSTRCTN,INSTN=instruction.INSUR=insuranceINTL=internationalINTRST〔D〕=interest〔ed〕INTST=interestINV,IVO=invoiceINVEST,INVSGT=investigateINVSGN=investigationI/O=instead ofI.O.P=irrespective of percentageIOT=in order toIOU=I owe youIRRESP=irrespectiveIRREV,IRVCBL=irrevocableISO=International Standards OrganizationIVO=in view ofJAL=Japan Air LinesJAN=JanuaryJAP=JapanJCQD=jacquard〔for textiles BIZ〕JKT=jacketJUL=JulyJUN=JuneKANS=KansasKC〔S〕=kilocycle〔s〕. KG〔S〕=kilogram〔s〕KL=kiloliterKM=kilometerKP=keepKV=kilovoltKW=kilowattKWH=kilowatt-hourKY=KentuckyL=letter,large,sterlingLAB,Lab=laboratoryLB〔S〕=pound〔s〕LCD=liquid-crystal diodeLCL=less than cartload lot,less than container load LDN=LondonLDT=light displacementLED=light emitting diodeLET=letterL/G=letter of guaranteeLIT=litreLMT=local mean timeLNTH=lengthLST=local standard timeLT,L/T=long tonLTE=late.LTR,LTTR=letterLVE=leaveO/A =on or aboutO/B =on boardOBLD=obligedOBS =observeOBT =obtainOC =our cableOC5 =our cable dated 5thOCC =occupiedO.C.P,OCP=overland common pointOCT =OctoberODR =orderOFC =officeOFCL=officialOFF =officeOFA,OFR〔S〕=offer〔s〕OK =all right or agreedOL =our letterOPEC=Organization of the Petroleum=Exporting countriesOPN =openOPND=openedOPNG=openingOPT =optionORD =ordinaryORIG,ORGNL=originalOT =our telex,our telegramOTLX=our telexOTHWS=otherwiseOURSLVS=ourselvesOZ =ounceOZWS=otherwisePA =PennsylvaniaPACKG=packingPAMP,PAM=pamphletPAT =patentPATTN=patternPAYMT,PAYT=paymentPCE,PC=piecePCT =percentPCTG=percentagePENN=PennsylvaniaPHLN=PhilippinePIA =Pakistan Air LinesP/INV=proforma invoiceP.I.C.C.=The People's Insurance Co. of China PKG =packing,packagePKTS=packetsPLS,PL=pleasePLT〔S〕=plate〔s〕POLY=polyesterPOSN=positionPOSS,POSSBL=possiblePRC =pricePREV=previousPROB=probablePROBM=problemPROD=produtionPROX=proximoPRVS=previousPRVT=privateP.S.T.,PST=Pacific Standard Time〔U.S.A.〕PUR =purchasePURCHS=purchasePURP=purposePVC=polyvinyl chloridePYMT=paymentQLTY =qualityQNTY =quantityQOT =quoteQSTN =question. QTN,QUTN=quotationQUOT,QUOTN=quotationR =areRCPT =receiptRCV =receiveRCVD =receivedRCVG,RECVG=receivingRD =read,roadRE =referringRECD,RECVD=receivedREF =referenceREFCON=refrigerated containerREG =registerREFD =registeredREGDG=regardingREGL =regularREIMB=reimbursementRELTNS=relationsRESPCTVLY=respectivelyREQ,REQST=requestREQMNT=requirementREQR =requireREQRMT=requirementREP =representativeREPT =reportRESN =reservationRESP =respectiveRESV =reserveREV =revisedRGDS =regards,best regardsRMKS =remarksRND =roundR/O =room only〔without breakfast〕〔for hotel business〕ROC =refer to our cableROL =refer to our letterRO/RO=roll on/roll offR/O/T=roll on tube〔for textiles business〕ROT =refer to our telegram〔telex〕ROTLX=refer to our telexRPT =repeat,reportRPTN =repetitionRPY =replyRQST =requestREPON=responsible〔bility〕R.S.V.P.=please reply〔repondez s'il vous plait〕RTRN =returnRYC =refer to your cableRYL =refer to your letterRYT =refer to your telexRYTLX=refer to your telex of August 24 RYTLX24/8=refer to your telex of August 24。

FDA英语术语大全

FDA英语术语大全FDA是什么意思，FDA得英文全称是什么？FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究完毕） NDA（NEW DRUG APPLICATION）：新药申请 ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品） TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药 DMF（DRUG MASTER FILE）：药物主文件（持有者为慎重起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。

只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、 NDA、ANDA时才能参考其内容） HOLDER：DMF持有者 CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规 PANEL：专家小组 BATCH PRODUCTION：批量生产；分批生产 BATCH PRODUCTION RECORDS：生产批号记录 POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监视 INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意承受治疗或试验） PRESCRIPTION DRUG：处方药 OTC DRUG （OVER—THE—COUNTER DRUG）：非处方药以上信息中国医药资讯网 FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究完毕） NDA（NEW DRUGAPPLICATION）：新药申请 ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请 EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品） TREATMENT IND：研究中的新药用于治疗 ABBREVIATED（NEW）DRUG：简化申请的新药 DMF（DRUG MASTER FILE）：药物主文件（持有者为慎重起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。

保险附加条款中英文对照

清除滑坡土石方特别除外条款
Sections
分段开挖施工条款
Serial Losses
连续损失特别条款
Special Conditions Concerning Safety Measures with Respect to Precipitation，Flood and Inundation
洪水特约条款
Hydrocarbon Processing Industries Clause 2
碳氢化合物加工业特别条款 2
Inland Transit Clause
内陆运输扩展条款
Laying Water Supply and Sewer Pipes Clause
铺设供水管、污水管特别条款
Leak Search Costs when Laying Pipelines Clause
独立承包人责任条款
Landlord’s Furniture, Fixtures & Fittings under Care Custody & Control of Insured
被保险人照料、保管或控制下的业主家具、装置及设施条款
Landlord’s Liability Clause
出租人责任条款
恐怖活动条款
Additional Insured Clause
附加被保险人条款
Advertising Signs & Decorations
广告及装饰物条款
Alteration, Maintenance, Repair and Decoration of the Premises
扩展在被保险地址内修理责任条款
商品展示条款
Defective Sanitation Liability Clause

美国FDA《联邦规章典集》(CFR)第21篇目录中文版

美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。

其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and Drug Administration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。

第21篇“食品与药品”（Tit le 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINIST RATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）1 一般强制执行规章GENERAL ENFORCEMENT REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS82 经认证的临时性列表的色素和规范的列表LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS83-98 [预留的] [Reserved]99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）100 总则GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL110 在制造、包装或者保存人类食品中的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 允许直接加入用于人类消费食品的食品添加剂FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION173 在用于人类消费的食品中允许的次直接的食品添加剂SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178 间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 179 在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184 被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 186 被确认为一般认为安全的间接食品物质INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 189 禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 制造、加工、包装或者保存药品的现行良好制造规范；总则CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS290 管制的药品CONTROLLED DRUGS299 药品；正式名称与已确定的名称DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）300 总则GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL330 一般认为安全与有效以及不错误标识的非处方人用药品OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE332 用于非处方的人类使用的抗胃肠气胀产品ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLYRECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUB CHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDA RDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。

人教版英语选择性必修一unit3 Theme parks—Fun and more than fun

人教版英语选择性必修一unit3 Themeparks—Fun and more than fun本节课的主题是主题公园，旨在通过阅读语篇，帮助学生研究世界上著名的三个主题公园，并掌握篇章结构和写作技巧。

本节课是一节读写课，旨在检验师生教与学的成果。

在学生已经掌握了阅读、听说、语法等技能的基础上，通过研究三个著名的主题公园，拓展学生的视野，启发学生从人与自然、人与社会的角度思考公园这一主题所蕴含的人文内涵和意义。

本节课的教学对象是高中二年级学生，他们已经有了一定的英语阅读技巧，但在分析语篇结构、语言特征、修辞特点等方面还有欠缺。

此外，学生的写作能力也有待提高。

因此，教师需要引导学生分析语篇结构、语言特征、修辞特点，并提供过程性指导，为下一步的写作活动作好铺垫。

在课堂中，教师应该以学生为中心，采用讨论、探究、小组合作研究等方式，帮助学生形成有效的研究策略和积极的研究态度。

总之，本节课旨在通过研究主题公园，提高学生的阅读和写作能力，拓展学生的视野，启发学生思考公园这一主题所蕴含的人文内涵和意义。

1.理解三个主题公园的特色和文化意义，掌握阅读策略，如skimming、scanning、find key n、Read for writing n等；2.分析语篇结构、语言特征、修辞特点等，提高整体把握文本的能力；3.提高词汇量，改善表达能力，丰富句式结构，增强篇章意识，提高写作水平；4.能够根据所喜欢的公园写出宣传短文，运用所学知识和技巧，展现语言表达能力。

教学重点1.三个主题公园的特色和文化意义；2.阅读策略的应用；3.语篇结构、语言特征、修辞特点等分析；4.提高写作水平。

教学难点1.整体把握文本；2.提高表达能力，丰富句式结构；3.运用所学知识和技巧，写出宣传短文。

教学方法1.阅读理解教学法；2.讨论式教学法；3.案例分析教学法；4.合作研究教学法；5.任务型教学法。

教学过程Step 1：导入引入本节课的主题，介绍三个主题公园的名称和特色，激发学生的研究兴趣。

国际贸易实务课后答案

Chapter5ⅠFOB 班轮条件FOB liner term清关customs clearanceFOB 吊钩下交货FOB Under Tackle平舱trim多式联运multimodal transport船舷ship’s rail内陆水运marine navigation on inland waterway理舱stowing shipping space卸货费discharge expense投保cover/procure/ effect/arrange insuranceCFR 卸至岸上（含着陆费）CFR Landed班轮liner ships单据买卖documentary sales/ buying and selling of documents CFR 舱底交货CFR Ex-ship’s HoldCFR 班轮条件CFR liner terms象征性交货symbolic deliveryⅡ１.Under CFR,buyer should effect insurance.２.Under CIF Ex-Ship’s Hold, the buyer should pay the discharge charges.３.Under CIF,the insured amount should be US ＄22000 if the contracted price is US＄20000.４.Under CIP,seller has to procure insurance against the buyer’s risk of loss of or damage to the goods during the carriage.５.The FAS term requires the seller to clear the goods for export.６.The DEQ term requires the buyer to proceed with the customs clearance for imports and payment of all customs duty.７.Under DDP,the seller must pay the costs of customs duties as well as all duties,taxes and other official charges payable upon exportation and importation of the goods.８.Under DDU the seller must give the buyer instant notice of the shipping of the goods as well as any other notice required in order to allow the buyer to take measure.Ⅲ１.The price quoted includes ５％commission on FOB basis.该报价为FOB 的价格并含５％的佣金。

巧记lie和lay的差别[资料]

巧记lie和lay的区别记忆口诀：规则撒谎，不规则躺；躺过下蛋，下蛋不规则。

解释：lie撒谎的过去式和过去分词是规则变化，lie躺的过去式和过去分词是不规则变化，lie躺的过去式是lay（下蛋），lay下蛋的过去式和过去分词是不规则变化。

即：lie--lied--lied 撒谎lyinglie--lay--lain 躺，放置lyinglay--laid--laid 产卵，下蛋laying例句：He wasn't telling the truth. He lied again. 他没有说出真相。

他再次说谎了。

She laid her shoulder on my shoulder. 她把肩膀放在我的肩上。

His books lay open on the desk when I went in. 当我进来的时候，他的书摊开放在桌上。

The hen is laying an egg. 母鸡正下蛋。

The city lies in the north of China. 这座城市位于中国北部。

名词性从句在句子中起名词作用的句子叫名词从句(Noun Clauses）。

名词从句的功能相当于名词词组, 它在复合句中能担任主语、宾语、表语、同位语、介词宾语等，因此根据它在句中不同的语法功能，名词从句又可分别称为主语从句、宾语从句、表语从句和同位语从句。

17.1 引导名词性从句的连接词引导名词性从句的连接词可分为三类：连接词：that,whether,if 不充当从句的任何成分）连接代词：what, whatever, who, whoever, whom,whose, which.连接副词：when, where, how, why不可省略的连词：1. 介词后的连词2. 引导主语从句和同位语从句的连词不可省略。

That she was chosen made us very happy.We heard the news that our team had won.比较：whether与if 均为"是否"的意思。

FDA’sGoodLaboratoryPractice

FDA’s Good Laboratory Practice摘要：GLP是怎么来的呢？我们追溯至1905年，一位名叫塞缪尔·霍普金斯的人，在科利尔杂志上发表了11篇文章，其内容是关于制药行业的一些欺诈现象。

这些文章不仅引起了人们的关注，更引起了人们的愤怒，以至于国会终于在1906年颁布了第一部《纯净食品和药品法》，这部法案对食品和药品的安全性及有效性未做相关规定。

1938年颁布了《联邦食品、药品和化妆品法案》，该法案对药品安全性进行了相关规定。

20世纪70年代，美国FDA在检查美国工业生物实验室和生物检测公司时，发现了这两实验室存在相当严重的问题，为此立即下令停止其进行临床前研究。

从调查结果看，这两个实验室不仅存在资料数据混乱，更有欺诈行为。

因此，FDA专门成立了起草GLP规范委员会，最终于1976年11月颁布了《GLP规范（草案）》。

GLP法规（21 CFR 58）主要适用于美国食品药品监督管理局监管的产品研究或市场许可而进行的非临床研究，其产品主要包括人用药和动物用药、生物制品、人用医疗器械,电子产品、食品和颜色添加剂以及饲料添加剂。

2016年8月，美国FDA发布联邦法规21CFR58——非临床研究质量管理规范的征求意见稿，推动实施3R原则，即在研究中实现动物减少（reduce）、优化（refine）和替代(replace)。

评论期于2017年1月结束，共收到了78条反馈意见，主要修改内容如下：1、§ 58.1 Scope：扩大了适用范围，增加了烟草制品2、§ 58.3 Definitions：增加一些新的定义，如Attending V eterinarian3、58.5 Sponsor Responsibilities：方案及方案变更需要委托方签字后才能生效4、58.15 Inspections：FDA的检查权力包括任何进行非临床实验室研究的人5、58.31 Testing Facility Management with Executive Responsibility：FM的职责增加，对GLP质量体系负责6、§ 58.33 Study Director：起草方案时与主治兽医协商7、§ 58.35 Quality Assurance Unit (QAU)：主QA对整个专题负责8、§ 58.130 Conduct of a nonclinical laboratory study：证明所有的分析方法都是准确的，足够精确，并且足够灵敏，能够产生准确和可重现的数据9、§ 58.180 Data quality and integrity：ALCOA，可溯源（Attributable），清晰(Legible)，同步(Contemporaneous)，原始(Original)，准确(Accurate)10、§ 58.185 Reporting of Nonclinical Laboratory Study Results: 对于中止的试验，专题负责人要写一份简短的书面总结陈述试验中止的原因并签名签日期11、§ 58.190 Storage and retrieval of records and data：所有试验完成后需要在2周内归档还有很多细节性的内容不再一一阐述，总而言之，对于GLP质量管理体系，各国都在不断的修改完善，药物非临床研究试验将在未来越做越好，为临床研究进行铺垫，更好的保证人们的用药安全。

美国FDA指导原则药品不良反应上市后报告指南英文原版

美国FDA指导原则药品不良反应上市后报告指南英文原版Title: FDA Guidelines for Reporting Post-Market Drug Adverse ReactionsIntroductionThe U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of drugs available in the market. One aspect of this responsibility is the monitoring and reporting of adverse reactions associated with the use of drugs post-marketing. This guideline aims to provide detailed instructions on how to report drug adverse reactions to the FDA.PurposeThe purpose of this guideline is to facilitate the reporting of adverse reactions associated with drugs that have been approved and are being used in the market. It enables healthcare professionals, consumers, and manufacturers to report adverse reactions promptly, thereby helping the FDA identify potential safety issues and take appropriate regulatory actions to protect public health.ScopeThe reporting of adverse reactions under this guideline applies to all prescription and non-prescription drugs,including biologics, vaccines, and generic drugs, indicated foruse in the United States. The guideline covers adverse reactions occurring both within and outside the United States.Reporting Requirements1. Mandatory Reporting: Manufacturers, packers, and distributors of drugs approved by the FDA must submit periodic safety reports containing information on any adverse drug reactions they receive.2. Voluntary Reporting:b. Consumers: Patients, caregivers, and other consumers can also report adverse reactions directly to the FDA using the MedWatch Reporting System.c. Foreign Regulatory Authorities: If an adverse reaction occurs outside the United States, foreign regulatory authorities are encouraged to report such events to the FDA.Reportable Events1. Serious Adverse Reactions: Any adverse reaction to a drug that results in death, a life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability, congenital anomaly, or requires intervention to prevent permanent impairment or damage.3. Adverse Reactions in Special Populations: Adverse reactions specific to particular populations, such as pregnantwomen, infants, elderly individuals, or individuals with certain medical conditions.4. Known Adverse Reactions: Adverse reactions that are already listed in the drug's labeling, but occur at a higher frequency or severity than expected.Reporting ProcessReporting adverse reactions involves the following steps:2. Submit the report electronically to the FDA through the MedWatch Reporting System.3. Include all available supporting documentation, such as laboratory test results, medical records, and any additional relevant information.Confidentiality and ProtectionConclusion。

医疗器械问卷调查表

附件V（生产质量保证体系）
Annex VI (Product Quality Assurance)
附件VI（产品质量保证体系）
Annex V (For sterility of Class 1 products)
附件V（第一类无菌产品的全面质量保证体系）
Annex V (For sterility under Article 12)
Annex IV (EC Verification)
附件IV（EC验证）
第3页共7页
QUESTIONNAIRE – MEDICAL DEVICES
Please define proposed scope of SGS registration for these standards, if applicable.
existing certification please use SGS Notification forms. 如果您已经是SGS的客户只需列明现在增加的认证申请。对于范围的扩展认证请用SGS的表格
3. Please return in electronic format or hard copy to your local SGS certification office as shown
Certification 认证
Please indicate with X the certification you wish to achieve with SGS 请用X标明您希望SGS提供的认证
ISO 9001: 2000, and please give details of any intended exclusions (clause numbers) ISO9001:2000认证，并给出想要删减的详细资料（标准的条款号）